Adherence With Iron Sprinkles Among High-Risk Infants

Anemia Clinical Trial

Official title:

Adherence With Iron Sprinkles Among High-Risk Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136266
• Other study ID #: CDC-NCCDPHP-MM-0835-O5/05
• Secondary ID: CDC-MM-0835-O5/0
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: February 2, 2016
• Start date: March 2005
• Est. completion date: December 2005

Study information

• Verified date: September 2007
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.

Description:

Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.

Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Months to 7 Months

Eligibility

Inclusion Criteria:

• Healthy infants

• Age 5-7 months

• Presenting for 6 months well-child care

• Caregiver speaks English or Spanish

Exclusion Criteria:

• Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)

• Inability to speak English or Spanish

• Use of vitamin or iron supplements in the previous three months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Drug:
• Ferrous sulphate drops with vitamins A, D, and C

• Ferrous fumarate sprinkles with vitamins and minerals

Locations

Country	Name	City	State
United States	Boston Medical Center Pediatric Primary Care Clinic	Boston	Massachusetts
United States	Whittier Street Health Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

Geltman PL, Hironaka LK, Mehta SD, Padilla P, Rodrigues P, Meyers AF, Bauchner H. Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops. J Pediatr. 2009 May;154(5) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	full adherence, use of iron supplements 6-7 days/week for 3 months
Secondary	iron deficiency at 9 months of age
Secondary	anemia at 9 months of age